Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Based on the considerations described in the document "Read-across substantiation C5-6 branched alkylmethyl-ethers” (incl. the supporting references Tuppurainen et al., 2007 and Niska et al., 2008), it can be concluded that the available information of TAME can be used to predict the sensitisation properties of the substance ‘C5-6 branched alkylmethyl-ethers’ with sufficient certainty.

TAME was considered not sensitising in a guinea pig Bühler test performed according to USEPA Toxic Substance Control Act specification and under GLP (Pharmaco LSR, 1995). The incidence index in the positive control animals was 100%. None of the animals induced and challenged with TAME showed a dermal response, the incidence index and severity score being zero.

Migrated from Short description of key information:
The substance is not expected to have skin sensitising properties.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
No information available. However, respiratory tract sensitisation is not expected as no positive human data is available suggesting that the substance causes respiratory tract sensitisation. In addition, there is no evidence of respiratory tract effects reported in repeated exposure inhalation studies in animals.

Justification for classification or non-classification

Based on the available data, TAME is considered to be not sensitising. In accordance with Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification of ATME is not necessary for sensitisation.

Based on the proposed read-across approach, this non-classification does also apply for C5-6 branched alkylmethyl-ethers.